Last Updated on March 20, 2023 by BIOMEDRIC
Rules and laws are today an integrated part of society. They are necessary for the safety and precautions of all that abound within a person’s daily trading and usage. The protection assumes mounting importance regarding the health and medical sector, here, the medical device industry; EU MDR 2017/745 is part of it.
In 2017, the European Union rules amended drastically from the beginning to end processes of the medical device industry to boost its reliability in society today. As the rules readjust with the ever-changing scenario of medical devices, one related to the industry must keep pace with the new regulations. The Medical Devices Regulation (MDR) sharpens from the Medical Device Directive (MDD) in this aspect.
Medical Device Directive vs. Medical Devices Regulation
The MDD that has spanned over two decades grew out of the vigilance and risk management that surfaced over time. The MDR has a technological cutting edge over unique identification and quality with newer and detailed chapters and more annexes.
Compared to the MDD, the MDR has put forth additional and specific rules for all the medical devices that will float into the market. The medical device manufacturers will have to adopt stricter certification obligations, labeling, documentation, and device identification for better efficiency of the devices and protection against loopholes.
Preclinical, Clinical and Post-clinical Stages
- The ISO 10993 lays down specific conditions for medical devices before using them on the human body. With the greater need in the EU countries, the new regulations cohere with the ISO frameworks and substantially help keep the medical device industry free from spuriousness. The ISO 10993 is also amended to intricate testing strategies, focusing more on the chemical, physical and biological aspects involved. Lives will not be played with.
- With greater emphasis on safety, the MDR will force medical device manufacturers to present more clinical evidence and post-market surveillance, giving it importance within the consumer protection side. The scope has included much more than the MDD, from a simple definition of med-useful devices to an all-inclusive one, even including the products combined with an ancillary medical device and the ones that are not directly or fundamentally for medical usage.
BIOMEDRIC Support for Medical Device Manufacturers
Here at BIOMEDRIC, the specialization in the quality control of medical devices, including the in-vitro diagnostic medical devices, confer with the new updated MDR regulations for utmost safety and trials. With a positive impact on the market and post-market surveillance, BIOMEDRIC looks forward to better market adaptation and efficacy.
Along with BIOMEDRIC, all companies need to jump into action to present a space for their medical devices. High quality and assurance of high quality mean a better market. All the safety tests and the advanced technological support that come with the medical and related products concurring with all the rules means an easy recognition and conversion into the mainstream of the medical industry.
Ready for all the medical body audits and the requirements that the manufacturers would have to face under the MDR regulations, the BIOMEDRIC platform ensures a high quality of medical devices for our use, especially in the pressing need of contemporary situations.
BIOMEDRIC ensures the three main stages, preclinical stage, clinical stage, and post-clinical stage, involved in the quality control of medical devices from all the manufacturers it supports, both clinically and non-clinically, are up to date. With a highly scientific and solution-oriented approach, BIOMEDRIC has debuted in 2020 shortly before the effective dates of EU MDR 2017/745 for medical devices and EU IVDR 2017/746 for in-vitro diagnostic medical devices, which are May 2021 and May 2022 respectively.
Not only this, but BIOMEDRIC also gives extensive briefings related to all aspects of medical devices, their types, usage, and the laws. The interface also promotes a user-friendly outlook to assessing the needs and use of the company, with due diligence to the regulations of EU MDR 2017/745.